Ken McLeod , I 3

15 March 2011

TO: THE TRANSPARANCY REVIEW PANEL: [email protected] THERAPEUTIC GOODS ADMINISTRATION

•

Dear Professor Pearce

Re: TGA Review: "Getting Information about Medicines and Medical Devices Made Easier"

I refer to the Review of the TGA currently being conducted, and that I notice that I might have missed the date for final submissions. I request that this submission be accepted, as it relates to a matter of public importance; that is the implied endorsement of dangerous and ineffective medical devices by the TGA.

I note that the Parliamentary Secretary for Health and Ageing, Catherine King, has announced that, "It is now easy for consumers to find 0 product name and the ingredients, de toils about the company, the date a product was approved for use in Australia and importantly any warningsabout the use of the product." 1

.1 read a recent report by Choice magazine on pharmacies. 2 That prompted me to go my local pharmacy last week, and what did I find? Ear candles! I was surprised to see that medical devices that are known to be dangerous and ineffective are on sale at a pharmacy which is part of a national chain, and is supposed to abide by the Pharmacy Guild's Code of Conduct. In fact, "surprised" does not cover my reaction; I was disgusted, horrified, and angry that these gadgets could be on sale legally. I was even more surprised, disgusted, horrified, and angry that these gadgets carried an ARTG number.

To the innocent bystander, an ARTG number implies an endorsement from the TGA, after supposedly passing tests for safety and efficacy.

I knew that it was pointless to complain to the pharmacist in charge: he takes his orders from Head Office.

I knew that it was pointless to complain to Head Office; they are only interested in the money and the safety of customers is dearly not a consideration. I knew that it was pointless to complain to the Pharmacy Guild; they are quite happy to support quacks and , and following their lack of a response to the awarding of the Australian Skeptic's Bent Spoon Award in 2006, it is clear that the Guild is an organisation without shame. The Skeptics' citation reads:

"Bent Spoon Award 2006: The pharmacists of Australia, who manage to forget their scientific training long enough to sell and (such as Homoeopathy and ear candles) in places where consumers should expect to get real medical supplies and advice." 3

So I now turn to the TGA and your review. A little bit of research found that the ARTG contains 19 brands of ear candles. 4

131710 Com plete Health & Harmony Pty Ltd - Ear Candle - Applicator, ear, single use

136293 Alternet Health & Detox - 270960 - Applicator, ear, single use

137388 Modern Business Concepts T/A Health Reflections - Health Refections Ear Candling Candles­ Applicator, ear, single use

137495 Windsor Clinic - Windsor Naturopathy Ear Wax Candle - Applicator, ear, single use

137617 Graeme Leishman T/A Byron Bay Ear Candles - Byron Bay Ear Candles - Applicator, ear, single use

137896 Birte Troup - Ear candle - Applicator, ear, single 'use

138197 Eastmed Distribution - T C Naturals Ear Candles - Applicator, ear, single use

144660 Lighthouse Ear Candles - Ear Candles - Applicator, ear, single use

148177 Candle Powers - Holistic Ear Candle - Applicator, ear, single use

148545 Ear Candles Australia - Healing Candles - Applicator, ear, single use

151046 Soul Serenity, Clarity Ear Candles, Applicator, ear, single use

151663 Allies Therapy (Australia) - Allies Ear Candles - Applicator, ear, single use [41591J

153159 Harmony Ear Candle� - Harmony Ear Candles - Applicator, ear, single use

156678 JD Health Pty Ltd - Harmony Cone Ear Candles - Applicator, ear, single use

159195 Honeycone Naturals, Honeycone Ear Candles - Applicator, ear, single use

162439 Global Product Focus - Natural Secret Ear Candles - Applicator, ear, single use

162485 R & B Ear Candles Pty Ltd - R & B Ear candles - Applicator, ear, single use 164598 Bodyzest Australia - Bodyzest Australia Ear Candles - Applicator, ear, single use, Non-Sterile

166333 Essenzza Health Pty Ltd - Essenzza Ear Candles - Applicator, ear, single use

Detailed information on one of these is:

"ARTG no 162439 Global Product Focus - Natural Secret Ear Candles - Applicator, ear, single use. Intended purpose: A device intended to be used to apply a simple treatment of ear cleansing directly to the ear. This treatment can be done e.g., by using a special cone which is loosely fitted to the ear opening and set alight (on fire) at the outer end. A warmth travels down the cone and cleanses the ear channel of excessive wax and impurities. This device is single use. Holistic device to enable health and wellbeing, not intended to treat, cure or mitigate any disease."

No public summary documentation on any of these products contains a warning that these are known to be dangerous and ineffective.

Yet a 1996 survey of 144 ear, nose, and throat physicians, found that 14 had seen patients who had been harmed by ear candling, including at least 13 cases of external burns, 7 cases of ear canal

obstruction with candle wax, and 1 perforated eardrum. 5

In addition, as the above article points out, ear candles do not remove excessive wax despite what is said in the in the TGA public summary document for ARTG: 162439.

What is the point of easier access to ARTG public summary information when it lists numerous shonky products "approved" by the TGA; fails to tell the truth that they don't work and doesn't mention well known dangers?

This is not greater TGA transparency; it is cowardice and outright lunacy.

The government and the TGA should be honest about what therapeutic goods do and do not! I submit that the TGA should develop some spine and:

1, start to tell the truth to the public; and

2, refuse any listing or registration for any device or medication if that is warranted; and

3, be prepared to confront quacks and charlatans in response to their bleating; and

4, tell the Minister if more stringent legislation is required; and

5, remember that the safety of the public comes first; and 6, apply severe penalties to people and organisations who sell dangerous, unlisted, or unregistered devices and medications.

I finish by saying that in my industry, aviation, the regulators are never afraid to tell it like it is, and to do whatever is required to improve the safety of the public. I submit that the TGA is exactly the opposite.

Yours sincerely

Ken McLeod

1 http://www.health.gov.au!internet/ministers!publishing.nsf/Content/mr-yrl1-ck-ck008.htm

2 http://www.choice.com.au/reviews-and-tests/food-and-heaIth/general-health/health-practitionersidubious­ pharmacv-products,aspx

3 http://www.skeptics.com.au/features/bent-spoon/

4 http:Uwww.tga.gov.au/docs/html/artg.htm

5 http://www.quackwatch.com/01QuackeryRelatedTopics/candling.html